Sophiris Bio Inc. Sophiris Bio Inc. is a Canadian urology company with operations based in San Diego developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), a large unsatisfied market. PRX302, the company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a pivotal trial by the end of 2012.
The pivotal trial is supported by a randomized, controlled Phase IIb study that met the objective and subjective endpoints used as the basis for current BPH drug approvals. Sophiris is advised by world-leading urologists, is backed by experienced investors, and is led by an experienced drug development team that has achieved more than twenty drug approvals including several blockbusters.
Ongoing Clinical Development
|Study ||Phase ||Trial Design |
|III On-going/Enrollment Completed (479 patients) ||Prospective, randomized, double-blind, placebo-controlled, transrectal treatment of PRX302, which will utilize the IPSS outcome measure evaluated at 12 months as the primary endpoint |
|PRX302-2-7 PCa |
|IIa Enrolling (approximately 20 patients) ||Open label, Phase 2a study, evaluating the safety and tolerability of targeted intraprostatic administration of PRX302 to treat men with histologically proven, clinically significant, localized, low to intermediate risk prostate cancer |
Completed Clinical Development
$SPHS was $40.00 in 2011 We will be back there soon enough.
|Study ||Phase |
(pts treated with PRX302
|Trial Design |
|IIb (61 pts) ||Randomized, double-blind, placebo-controlled, transperineal treatment of PRX302 |
|PRX302-2-06 BPH ||I/II (32 pts) ||Randomized dose escalation, multicenter trial of a single transrectal intraprostatic treatment of PRX302 |
Phase 2a BPH
|IIa (18 pts) ||Open-label, safety, volume escalation clinical trial of a single transperineal treatment of PRX302 |
|I (15 pts) ||Open-label, safety, dose escalation clinical trial of a signal transperineal intraprostatic treatment of PRX302 |
|PRX302 PCa ||I (24 pts) ||Open-label, safety and tolerability, dose escalation trial of PRX302 in patients with biopsy-proven, locally-recurrent prostate cancer |
|PRX302 PCa ||II (6 pts) ||Open-label clinical trial in locally-recurrent prostate cancer |